MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067)

Event Date 08/16/2015

Event Type  Death  

Manufacturer Narrative

(b)(4) the end stage renal disease death notification (form 2746) lists the primary cause of death as septicemia, other.Additionally, the esrd death notification form noted secondary causes of cardiomyopathy, pulmonary infection (pneumonia, influenza), and chronic obstructive lung disease (copd).The post market surveillance department is in the process of reviewing patient medical records related to this event.This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.The post market surveillance department has received patient medical records and treatment sheets for review.Both a clinical investigation (ci) and a plant investigation are in process.A supplemental mdr will be submitted upon completion of these activities.

Event Description

An inpatient user facility reported that a patient was sent to the hospital on (b)(6) 2015 after receiving hemodialysis (hd) therapy.The patient subsequently expired on (b)(6) 2015 while hospitalized due to septicemia.On (b)(6) 2015 at 11:50 am the hd therapy was initiated and the patient received 500 ml normal saline (ns).At 12:20 pm the patient received an additional 200ml ns due to low blood pressure.At 1:30 pm the patient was administered an additional 500 ml ns per doctors order due to continued low bp.An additional 250 ml were administered at 1:46 pm.At 2:20 pm a final 250 ml ns bolus was administered to the patient.At 2:52 pm, the hd treatment ended; the patient completed the full treatment time.No product malfunctions occurred, identified, or alleged during the pre-hospitalization hd treatment.Post treatment, the medical physician performed a routine monthly dialysis examination where low blood pressure and general malaise were noted.The physician recommended the patient be admitted to the hospital following the assessment.The patient passed away on (b)(6) 2015 in the hospital.The 2008k hemodialysis machine is not available for evaluation.The dialyzer and bloodline are not available for evaluation by the manufacturer as both were discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.

Manufacturer Narrative

Manufacturing investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius blood lines from the reported catalog number (03-2742-9) shipped to this account within the selected time frame.A records review was performed on the 6 lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.Clinical investigation: the patient medical records were provided by the facility on march 3, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.A (b)(6) years old, female end stage renal disease (esrd) patient on intermittent in-center hemodialysis (hd) therapy, being carried out daily through fresenius dialysis products, started hd therapy on (b)(6) 2012.On (b)(6) 2015, the patient¿s treatment was terminated 3 hours into a 4 hour prescription due to a complaint of ¿feeling bad.¿ the patient was sent to an emergency department due to persistent hypotension despite interventions, and was admitted.According to the received document titled ¿esrd death notification,¿ the patient died on (b)(6) 2015.The place of death was at a hospital, modality at the time of death was in-center hemodialysis (hd), renal replacement therapy was not discontinued prior to the death, the patient was not receiving hospice care prior to the death, primary cause of death was septicemia, other, with secondary causes of cardiomyopathy, pulmonary infection (pneumonia, influenza), and chronic obstructive lung disease (copd).There is no documentation in the medical record supporting a possible association between the fresenius dialysis products, the event of hypotension, the outcomes of hospital admission and death.However, there is a certain association between the event of hypotension with the consumption of opioid analgesic medications and the episode of septicemia.Also, there is a certain association between the event of septicemia and the outcome of death.Medical records did not contain additional laboratory results for review.

Event Description

At 11:46 am, a 3,000unit heparin bolus was administered via intravenous push (ivp).At 2:52 pm, the treatment was completed, with ultrafiltration goal of net positive 1,900ml.The treatment terminated 3 hours into a 4 hour prescription due to a complaint of feeling bad.The patient was sent to an emergency department due to persistent hypotension despite interventions, and was admitted.Hemodialysis orders from (b)(6) 2015 noted the following: f180nre optiflux dialyzer, dialysate flow rate 800ml/min, blood flow rate 400ml/min, 2 potassium, 2 calcium, 1 magnesium, 100 dextrose, sodium 138meq/l, bicarbonate machine setting 32meq/l, scheduled hours 4, estimated dry weight (b)(6).Machine setup from (b)(6) 2015 noted the following: fresenius 2008k hd machine, machine conductivity 13.8, meter conductivity 13.8, ph 7.0, machine temperature 36.9 degrees celsius, pressure holding test passed, high flux verified, air detector armed, alarms verified, no bleach.

• Brand Name: FRESENIUS COMBISET 2008, NO HEPARIN LINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5538339
• MDR Text Key: 41562816
• Report Number: 8030665-2016-00158
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Other Device ID Number: 00840861100309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 68 YR
• Patient Weight: 77